Burn Pain
Conditions
Keywords
Burn pain, Procedural pain, Sublingual fentanyl, Morphine
Brief summary
The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.
Detailed description
The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury. It will be compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury.
Interventions
DRUGSublingual Fentanyl Spray
Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).
Sponsors
Loyola University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject capable of giving consent * Age 18-65 * Total burn surface area greater than or equal to 5% * Opioid tolerant * BMI less than or equal to 35
Exclusion criteria
* Subjects with cognitive or psychiatric impairment that would preclude study participation or compliance with protocol * Allergy to fentanyl, morphine, naloxone * Pregnancy, intent to become pregnant or lactating * Evidence of burn injury to oral mucosa * Active illicit drug use or illicit drug abuse history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Relief | 60 min | Patients suffering from burn injuries will receive sublingual fentanyl spray (Subsys) to address procedural pain (dressing changes/minor debridement). It will be compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury. |
Countries
United States
Participant flow
Pre-assignment details
There are no pre-assignment details.
Participants by arm
| Arm | Count |
|---|---|
| Sublingual Fentanyl Spray Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.
Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement). | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Sublingual Fentanyl Spray |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Pain Relief
Patients suffering from burn injuries will receive sublingual fentanyl spray (Subsys) to address procedural pain (dressing changes/minor debridement). It will be compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury.
Time frame: 60 min
Population: No participants are included in this analysis because the trial was terminated prematurely. As a result, data to assess primary and secondary study aims are incomplete or entirely unavailable for summary or statistical comparisons.
| Arm | Measure | Value |
|---|---|---|
| Sublingual Fentanyl Spray | Pain Relief | 0 |